ID

43207

Description

PACCT-1 TAILORx Follow-up Form NCT00310180 Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DF4324-6BB2-192D-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DF4324-6BB2-192D-E044-0003BA3F9857

Keywords

Versions (5)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
  4. 6/8/15 6/8/15 -
  5. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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PACCT-1 TAILORx Follow-up Form NCT00310180

English

No Instruction available.

1 forms  
  1. StudyEvent: PACCT-1 TAILORx Follow-up Form
    1. No Instruction available.
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Follow-up Report Period
Description

Follow-up Report Period

Follow-up Report Period (since registration - Choose one x)
Description

PatientFollow-upTimePeriodType

Data type

text

Alias
NCI Metathesaurus ObjectClass
C0030705
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property-2
C1522577
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Reporting period
Description

Reporting period

Reporting Period Start Date (mm/dd/yyy)
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (mm/dd/yyy)
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Breast: Vital Status
Description

Breast: Vital Status

Patient Vital Status
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death (mm/dd/yyy)
Description

Date last contact

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Primary Cause of Death (if applicable)
Description

Primary Cause of Death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Description

Cause of Death, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Breast: Disease Follow-up Status
Description

Breast: Disease Follow-up Status

Date of Last Clinical Assessment (only provide date if assessment since submission of previous follow-up form)
Description

Follow-Up Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Not done (Check here and skip the rest of Section II if a more recent clinical assessment was not done.)
Description

AssessmentMethodText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Breast: Notice Of Progression - Advanced Disease
Description

Breast: Notice Of Progression - Advanced Disease

Has the patient been diagnosed with first ipsilateral breast tumor recurrence (since submission of the last follow-up form)
Description

RecurrentIpsilateralBreastNeoplasmDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C14173
UMLS 2011AA ObjectClass-3
C2945760
NCI Thesaurus ObjectClass-4
C25308
UMLS 2011AA ObjectClass-4
C0441989
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of first ipsilateral breast tumor recurrence (If yes:)
Description

RecurrentIpsilateralBreastNeoplasmDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C14173
UMLS 2011AA ObjectClass-3
C2945760
NCI Thesaurus ObjectClass-4
C25308
UMLS 2011AA ObjectClass-4
C0441989
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C15220
UMLS 2011AA ValueDomain-2
C0011900
Method of Diagnosis (For contralateral breast primaries:)
Description

DiagnosisMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Specify
Description

DiagnosisMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
IBTR histology (NOTE: See TAILORx Forms Completion Guidelines for IBTR definitions)
Description

RecurrentIpsilateralBreastTumorHistologyCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C14173
UMLS 2011AA ObjectClass-3
C2945760
NCI Thesaurus ObjectClass-4
C25308
UMLS 2011AA ObjectClass-4
C0441989
NCI Thesaurus Property
C16681
UMLS 2011AA Property
C0019638
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
Iib - Local-regional Recurrence
Description

Iib - Local-regional Recurrence

Has the patient been diagnosed with first local-regional recurrence or progression (since submission of the last follow-up form)
Description

RecurrentDiseaseCancerProgressionFirstLocal-RegionalDiagnosisIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25388
UMLS 2011AA Property
C1947913
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus Property-4
C19987
UMLS 2011AA Property-4
C0242656
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date of First Local-Regional Recurrence (If yes: - mm/dd/yyyy)
Description

RecurrentDiseaseFirstLocal-RegionalDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25388
UMLS 2011AA Property
C1947913
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site of first local-regional recurrence (s check all that apply; all sites refer to the same side as the original primary)
Description

BreastCarcinomaLocal-RegionalRecurrentDiseaseAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25388
UMLS 2011AA Property
C1947913
NCI Thesaurus Property-2
C38155
UMLS 2011AA Property-2
C0277556
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
Method of Diagnosis (For contralateral breast primaries:)
Description

DiagnosisMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Specify
Description

DiagnosisMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Iic - Distance Recurrence
Description

Iic - Distance Recurrence

Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form)
Description

Neoplasm recurrence, Distal

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027627
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25180
Date of First Distant Recurrence (mm/dd/yyyy)
Description

RecurrentDiseaseFirstDistantDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site(s) of First Distant Recurrence (Indicate - check all that apply at the completion of the metastatic workup)
Description

RecurrentDiseaseFirstDistantDiagnosisAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Other specify
Description

RecurrentDiseaseFirstDistantDiagnosisSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Method of Diagnosis (For contralateral breast primaries:)
Description

DiagnosisMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Specify
Description

DiagnosisMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Section Iii - New Primary Cancers
Description

Section Iii - New Primary Cancers

Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Description

BreastNewCancerDiagnosisIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C9305
UMLS 2011AA ObjectClass-3
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Site of New Primary (Recommended term - CRF shows "specify sites")
Description

NewCancerSiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
Date of diagnosis (If yes: - )
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Method of Diagnosis (For contralateral breast primaries:)
Description

DiagnosisMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Specify
Description

DiagnosisMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
Section Iv - Treatment
Description

Section Iv - Treatment

Has the patient received any chemotherapy during this reporting period?
Description

ChemotherapyAdministeredInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Has the patient received any hormone therapy during this reporting period?
Description

HormoneTherapyReportPeriodAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did patient switch type of hormonal therapy during this report period
Description

AdjuvantHormoneTherapyChangeInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Specify reason for switch in endocrine therapy (If yes,)
Description

AdjuvantHormoneTherapyChangeReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Other, specify
Description

AdjuvantHormoneTherapyChangeSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Start date of new hormonal therapy
Description

NewAdjuvantHormoneTherapyAdministeredDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify new type of hormonal therapy given
Description

AdjuvantHormoneTherapyChangeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Other, specify
Description

NewAdjuvantHormoneTherapyAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Specify which Aromatase Inhibitor was given (If aromatase inhibitor:)
Description

AdjuvantAromataseInhibitorHormoneTherapyChangeType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

AdjuvantAromataseInhibitorHormoneTherapyChangeSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Tamoxifen (Answer Yes or No for each of the following therapies the patient consistently took during this reporting period:)
Description

HormoneTherapyTamoxifenReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C855
UMLS 2011AA Property
C0039286
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Aromatase Inhibitor
Description

AromataseInhibitorReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Specify which Aromatase Inhibitor was given
Description

AromataseInhibitorReceivedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Specify
Description

AromataseInhibitorReceivedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Other
Description

HormoneTherapyOtherReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Specify (If yes, specify)
Description

HormoneTherapyOtherReceivedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Did patient receive Ovarian Function Suppression (OFS) during this follow-up period?
Description

OvarianAntiestrogenHormoneTherapyAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Ovarian Function Suppression Type
Description

OvarianAntiestrogenHormoneTherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

OvarianAntiestrogenHormoneTherapyAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was all hormonal therapy discontinued this report period
Description

HormoneTherapyDiscontinuedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Date any hormonal therapy last given (If yes, - mm/dd/yyyy)
Description

HormoneTherapyLastAdministeredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Footer Module
Description

Footer Module

Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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1 forms
  1. StudyEvent: PACCT-1 TAILORx Follow-up Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item Group
Follow-up Report Period
Item
Follow-up Report Period (since registration - Choose one x)
text
C0030705 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Follow-up Report Period (since registration - Choose one x)
CL Item
6 Months (6 months post registration)
CL Item
12 Months (12 months post registration)
CL Item
18 Months (18 months post registration)
CL Item
2 Years (24 Months post registration)
CL Item
30 Months (30 months post registration)
CL Item
3 Years (36 months post registration)
CL Item
42 Months Post Registration (42 Months Post Registration)
CL Item
4 Years (48 months post registration)
CL Item
54 Months Post Registration (54 Months Post Registration)
CL Item
5 Years (60 months post registration)
CL Item
6 Years (72 months post registration)
CL Item
84 Months Post Registration (84 months post registration)
CL Item
8 Years (96 months post registration)
CL Item
9 Years (108 months post registration)
CL Item
10 Years (120 months post registration)
CL Item
11 Years Post Registration (132 Months Post Registration)
CL Item
12 Years Post Registration (144 Months Post Registration)
CL Item
13 Years Post Registration (156 Months Post Registration)
CL Item
14 Years Post Registration (168 Months Post Registration)
CL Item
15 Years Post Registration (180 Months Post Registration)
CL Item
16 Years Post Registration (192 Months Post Registration)
CL Item
17 Years Post Registration (204 Months Post Registration)
CL Item
18 Years Post Registration (216 Months Post Registration)
CL Item
19 Years Post Registration (228 Months Post Registration)
CL Item
20 Years Post Registration (240 Months Post Registration)
Item Group
Reporting period
Reporting Period Start Date
Item
Reporting Period Start Date (mm/dd/yyy)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (mm/dd/yyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
Breast: Vital Status
Item
Patient Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Patient Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (mm/dd/yyy)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Cardiovascular Disease (Due to cardiovascular disease)
CL Item
Due To Other Chronic Disease (Due to other chronic disease)
CL Item
Due To Second Primary Or Other Malignancy (Due to second primary or other malignancy)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Breast: Disease Follow-up Status
Follow-Up Date
Item
Date of Last Clinical Assessment (only provide date if assessment since submission of previous follow-up form)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
AssessmentMethodText
Item
Not done (Check here and skip the rest of Section II if a more recent clinical assessment was not done.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Item Group
Breast: Notice Of Progression - Advanced Disease
RecurrentIpsilateralBreastNeoplasmDiagnosisInd-2
Item
Has the patient been diagnosed with first ipsilateral breast tumor recurrence (since submission of the last follow-up form)
boolean
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RecurrentIpsilateralBreastNeoplasmDiagnosisDate
Item
Date of first ipsilateral breast tumor recurrence (If yes:)
date
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus ValueDomain-2)
C0011900 (UMLS 2011AA ValueDomain-2)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
CL.14
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item
IBTR histology (NOTE: See TAILORx Forms Completion Guidelines for IBTR definitions)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.6
Code List
IBTR histology (NOTE: See TAILORx Forms Completion Guidelines for IBTR definitions)
CL Item
Invasive Carcinoma (Invasive Carcinoma)
C9480 (NCI Thesaurus)
C1334274 (UMLS 2011AA)
CL Item
Ductal Carcinoma In Situ (Ductal carcinoma in situ)
CL Item
Both Invasive Carcinoma And Ductal Carcinoma In Situ (Both invasive carcinoma and DCIS)
Item Group
Iib - Local-regional Recurrence
RecurrentDiseaseCancerProgressionFirstLocal-RegionalDiagnosisIndicator
Item
Has the patient been diagnosed with first local-regional recurrence or progression (since submission of the last follow-up form)
boolean
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
RecurrentDiseaseFirstLocal-RegionalDiagnosisDate
Item
Date of First Local-Regional Recurrence (If yes: - mm/dd/yyyy)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Site of first local-regional recurrence (s check all that apply; all sites refer to the same side as the original primary)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
CL.8
Code List
Site of first local-regional recurrence (s check all that apply; all sites refer to the same side as the original primary)
CL Item
Ipsilateral Axillary Lymph Nodes And/or Soft Tissue (Ipsilateral axillary lymph nodes and/or soft tissue)
CL Item
Ipsilateral Internal Mammary Nodes (Ipsilateral internal mammary nodes)
CL Item
Ipsilateral Infraclavicular Nodes (Ipsilateral infraclavicular nodes)
CL Item
Ipsilateral Supraclavicular Nodes (Ipsilateral supraclavicular nodes)
CL Item
Ipsilateral Chest Wall (Ipsilateral chest wall)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
CL.14
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item Group
Iic - Distance Recurrence
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form)
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
RecurrentDiseaseFirstDistantDiagnosisDate
Item
Date of First Distant Recurrence (mm/dd/yyyy)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Site(s) of First Distant Recurrence (Indicate - check all that apply at the completion of the metastatic workup)
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.11
Code List
Site(s) of First Distant Recurrence (Indicate - check all that apply at the completion of the metastatic workup)
CL Item
Bone (Bone(s))
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Central Nervous System (Central Nervous System (e.g., brain, meninges))
C12438 (NCI Thesaurus)
C3714787 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung(s))
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Positive Lymph Node (Non-regional lymph node(s))
C27296 (NCI Thesaurus)
C0746319 (UMLS 2011AA)
CL Item
Pleura (Pleura (pleural effusion))
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
CL Item
Skin (Skin (excluding ipsilateral chest wall))
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
RecurrentDiseaseFirstDistantDiagnosisSpecify
Item
Other specify
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
CL.14
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item Group
Section Iii - New Primary Cancers
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.13
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Ductal Carcinoma In Situ Of Contralateral Breast (Yes, ductal carcinoma in situ of contralateral breast)
CL Item
Yes, Invasive Disease In Contralateral Breast (Yes, invasive disease in contralateral breast)
CL Item
Yes, Ductal Carcinoma In Situ Of Ipsilateral Breast (Yes, DCIS of ipsilateral breast)
CL Item
Yes, All Other Sites (Yes, all other sites)
NewCancerSiteText
Item
Site of New Primary (Recommended term - CRF shows "specify sites")
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
NewCancerDiagnosisDate
Item
Date of diagnosis (If yes: - )
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
CL.14
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item Group
Section Iv - Treatment
Item
Has the patient received any chemotherapy during this reporting period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.15
Code List
Has the patient received any chemotherapy during this reporting period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Chemotherapy Continuing (Yes, chemotherapy continuing)
CL Item
Yes, Chemotherapy Completed (Yes, chemotherapy completed)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
HormoneTherapyReportPeriodAdministeredInd-3
Item
Has the patient received any hormone therapy during this reporting period?
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
AdjuvantHormoneTherapyChangeInd-3
Item
Did patient switch type of hormonal therapy during this report period
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
Item
Specify reason for switch in endocrine therapy (If yes,)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
CL.18
Code List
Specify reason for switch in endocrine therapy (If yes,)
CL Item
Planned Switch For Therapeutic Reason (Planned switch for therapeutic reason)
CL Item
Adverse Events From Prior Hormonal Therapy (Adverse events from prior hormonal therapy)
CL Item
Both Planned Switch For Therapeutic Reason And For Adverse Events From Prior Hormonal Therapy (Both)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AdjuvantHormoneTherapyChangeSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
NewAdjuvantHormoneTherapyAdministeredDate
Item
Start date of new hormonal therapy
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Specify new type of hormonal therapy given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
CL.19
Code List
Specify new type of hormonal therapy given
CL Item
Aromatase Inhibitor (Aromatase Inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
NewAdjuvantHormoneTherapyAdministeredSpecify
Item
Other, specify
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Specify which Aromatase Inhibitor was given (If aromatase inhibitor:)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.20
Code List
Specify which Aromatase Inhibitor was given (If aromatase inhibitor:)
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AdjuvantAromataseInhibitorHormoneTherapyChangeSpecify
Item
Other, specify
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
HormoneTherapyTamoxifenReceivedInd-3
Item
Tamoxifen (Answer Yes or No for each of the following therapies the patient consistently took during this reporting period:)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
AromataseInhibitorReceivedInd-2
Item
Aromatase Inhibitor
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
Item
Specify which Aromatase Inhibitor was given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
CL.23
Code List
Specify which Aromatase Inhibitor was given
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AromataseInhibitorReceivedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
HormoneTherapyOtherReceivedInd-3
Item
Other
boolean
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
HormoneTherapyOtherReceivedSpecify
Item
Specify (If yes, specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
Item
Did patient receive Ovarian Function Suppression (OFS) during this follow-up period?
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.25
Code List
Did patient receive Ovarian Function Suppression (OFS) during this follow-up period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ovarian Function Suppression Type
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.26
Code List
Ovarian Function Suppression Type
CL Item
Medical Suppression Of Ovarian Function (Medical suppression)
CL Item
Bilateral Surgical Oophorectomy (Oophorectomy)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Radiation Therapy (Ovarian radiation)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
OvarianAntiestrogenHormoneTherapyAdministeredSpecify
Item
Other, specify
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
HormoneTherapyDiscontinuedInd-2
Item
Was all hormonal therapy discontinued this report period
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
HormoneTherapyLastAdministeredDate
Item
Date any hormonal therapy last given (If yes, - mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item Group
Footer Module
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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